8/21/2013 7:46:53 AM
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On August 19, 2013, Alexion Pharma (Nasdaq: ALXN) International Sárl, a subsidiary of Alexion Pharmaceuticals, Inc., initiated a voluntary recall and replacement of the remaining vials of a single lot of Soliris® (eculizumab) due to the presence of visible particles in a limited number of vials in this single lot. Alexion estimates that the portion of the current affected lot being replaced in hospitals represents approximately 1-2% of the monthly vial consumption. The particles were recently observed by Alexion as part of its routine testing of retained samples following vial filling, packaging, and labeling by a third party contract vialer that began performing services for Alexion in 2012.
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